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Comparison Between FFR Guided Revascularization Versus Conventional Strategy in Acute STEMI Patients With MVD. (CompareAcute)

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ClinicalTrials.gov Identifier: NCT01399736
Recruitment Status : Completed
First Posted : July 22, 2011
Results First Posted : July 23, 2020
Last Update Posted : August 11, 2020
Sponsor:
Collaborator:
Abbott Medical Devices
Information provided by (Responsible Party):
Maasstad Hospital

Tracking Information
First Submitted Date  ICMJE July 20, 2011
First Posted Date  ICMJE July 22, 2011
Results First Submitted Date  ICMJE May 14, 2020
Results First Posted Date  ICMJE July 23, 2020
Last Update Posted Date August 11, 2020
Study Start Date  ICMJE July 2011
Actual Primary Completion Date October 31, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 21, 2020)
  • Number of Participants With the Composite Endpoint of MACCE [ Time Frame: 12 months ]
    Number of participants with the composite endpoint of all cause mortality non-fatal Myocardial Infarction, any Revascularisation and Cerebrovascular Events (MACCE) at 12 months between groups
  • Number of Participants With Death From Any Cause [ Time Frame: 12 months ]
    Number of participants with all cause mortality at 12 months between groups
  • Number of Participants With Cardiac Death [ Time Frame: 12 months ]
    Number of participants with Cardiac mortality at 12 months between groups
  • Number of Participants With Spontaneous MI [ Time Frame: 12 months ]
    Number of participants with Spontaneous Myocardial Infarction at 12 months between groups
  • Number of Participants With Periprocedural MI [ Time Frame: 12 months ]
    Number of participants with Periprocedural Myocardial Infarction at 12 months between groups
  • Number of Participants With Revascularization - PCI [ Time Frame: 12 months ]
    Number of participants with revascularization PCI at 12 months between groups
  • Number of Participants With Revascularization - CABG [ Time Frame: 12 months ]
    Number of participants with revascularization CABG at 12 months between groups
  • Number of Participants With Cerebrovascular Event [ Time Frame: 12 months ]
    Number of participants with Cerebrovascular event at 12 months between groups
Original Primary Outcome Measures  ICMJE
 (submitted: July 21, 2011)
Composite endpoint of MACCE [ Time Frame: 12 months ]
Composite endpoint of all cause mortality non-fatal Myocardial Infarction, any Revascularisation and Cerebrovascular Events (MACCE) at 12 months between groups ( a+b versus c-f).
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 21, 2020)
  • Number of Participants With Composite Endpoint of NACE (Any First Event) [ Time Frame: 12 months ]
    Number of participants with Composite endpoint of Cardiac death, Myocardial Infarction, any Revascularisation, Stroke and Major bleeding at 12 months (NACE i.e. Net Adverse Clinical Events)
  • Number of Participants With Death From Any Cause or MI [ Time Frame: 12 months ]
    Number of participants with Part of composite NACE-Death from any cause or Myocardial Infarction at 12 months
  • Number of Participants With Major Bleeding [ Time Frame: 12 months ]
    Number of participants with Major bleeding at 12 months - Part of composite NACE
  • Number of Participants With Any Bleeding at 12 Months [ Time Frame: 12 months ]
    Number of participants with any bleeding at 12 months - part of composite endpoint NACE
  • Number of Participants With Any Bleeding at 48 Hours [ Time Frame: 48 hours ]
    Number of participants with any bleeding at 48 hours - part of composite endpoint NACE
  • Number of Participants With Hospitalization [ Time Frame: 12 months ]
    Number of participants with hospitalization for heart failure, unstable angina or chest pain
  • Number of Participants With Revascularization [ Time Frame: 12 months ]
    Number of participants with any revascularization-Part of composite endpoint NACE
  • Number of Participants With Stent Thrombosis [ Time Frame: 12 months ]
    Number of participants with Stent Thrombosis - Part of composite endpoint NACE
  • Number of Participants With Primary Endpoint Outcome MACCE (Any First Event) at 3 Year [ Time Frame: 3 year ]
    Number of participants with Composite primary endpoint MACCE (any first event) at 3 year
  • Number of Participants With All Cause Death at 3 Year [ Time Frame: 3 year ]
    Number of participants with Composite endpoint MACCE (any first event) at 3 year - all cause death
  • Number of Participants With Cardiac Death at 3 Year [ Time Frame: 3 year ]
    Number of participants with Composite endpoint MACCE (any first event) at 3 year - Cardiac death
  • Number of Participants With Spontaneous MI at 3 Year [ Time Frame: 3 year ]
    Number of participants with Composite endpoint MACCE (any first event) at 3 year - Spontaneous MI
  • Number of Participants With Peri-procedural MI at 3 Year [ Time Frame: 3 year ]
    Number of participants with Composite endpoint MACCE (any first event) at 3 year - Peri-procedural MI
  • Number of Participants With Urgent Revascularization at 3 Year [ Time Frame: 3 year ]
    Number of participants with Composite endpoint MACCE (any first event) at 3 year - urgent revascularisation
  • Number of Participants With Elective Revascularization at 3 Year [ Time Frame: 3 year ]
    Number of participants with Composite endpoint MACCE (any first event) at 3 year -elective revascularisation
  • Number of Participants With Cerebrovascular Event [ Time Frame: 3 year ]
    Number of participants with Composite endpoint MACCE (any first event) at 3 year -Cerebrovascular event
  • Number of Participants With Composite Endpoint of NACE (Any First Event) at 3 Year [ Time Frame: 3 years ]
    Number of participants with Composite endpoint of Cardiac death, Myocardial Infarction, any Revascularisation, Stroke and Major bleeding at 3 year (NACE i.e. Net Adverse Clinical Events)
  • Number of Participants With Death From Any Cause or MI [ Time Frame: 3 year ]
    Number of participants with Part of composite NACE-Death from any cause or Myocardial Infarction at 3 year
  • Number of Participants With Major Bleeding at 3 Year [ Time Frame: 3 year ]
    Number of participants with Part of composite endpoint NACE- Major bleeding at 3 year
  • Number of Participants With Hospitalization [ Time Frame: 3 year ]
    Number of participants with Hospitalization for heart failure, unstable angina, MI
  • Number of Participants With Hospitalization at 3 Year [ Time Frame: 3 year ]
    Number of participants with Hospitalization for heart failure, unstable angina, MI and/or chest pain
  • Number of Participants With Stent Thrombosis at 3 Year [ Time Frame: 3 year ]
    Number of participants with Stent Thrombosis at 3 year - Part of composite endpoint NACE
  • Number of Participants With Any Bleeding at 3 Year [ Time Frame: 3 year ]
    Number of participants with any bleeding at 3 year - Part of composite endpoint NACE
Original Secondary Outcome Measures  ICMJE
 (submitted: July 21, 2011)
  • Primary endpoint in subgroups [ Time Frame: 12, 24 and 36 months ]
    Primary endpoint rates at 12, 24 and 36 months in the subgroup of patients receiving staged or acute PCI treatment for FFR positive lesions in the non-IRA vs the subgroup of patients with FFR positive lesion that received optimal medical treatment. {figure 2, subgroups (a+c) vs subgroup d}
  • Primary endpoint in subgroups [ Time Frame: 12, 24 and 36 months ]
    Primary endpoint rates at 12, 24 and 36 months in the subgroup of patients receiving acute PCI treatment for FFR positive lesions in the non-IRA vs the subgroup of patients receiving staged PCI treatment for FFR positive lesions in the non-IRA (figure 2 subgroups a vs c)
  • Primary endpoint in subgroups [ Time Frame: 12, 24 and 36 months ]
    Primary endpoint rates at 12, 24 and 36 months in the subgroup of patients receiving staged PCI treatment for FFR negative lesions in the non-IRA vs the subgroup of patients not receiving PCI treatment for FFR negative lesions in the non-IRA. ( figure 2 subgroups e vs b+ f)
  • Composite endpoint of NACE [ Time Frame: 12, 24 and 36 months ]
    Composite endpoint of Cardiac death, Myocardial Infarction, any Revascularisation, Stroke and Major bleeding at 12, 24 and 36 months (NACE i.e. Net Adverse Clinical Events)
  • Composite endpoint hospitalisation HF and UAP [ Time Frame: 12 months ]
    A composite of hospitalisation for heart failure and unstable angina pectoris at 12 months
  • Medium arterial blood pressure [ Time Frame: 5 min ]
    Medium of the arterial blood pressure difference before and 5 min after non culprit PCI
  • All cause mortality and MI [ Time Frame: 12 months ]
    All cause mortality or Myocardial infarction at 12 months
  • Revascularisation [ Time Frame: 12 months ]
    Any revascularisation at 12 months
  • Stent thrombosis [ Time Frame: 12 months ]
    Stent thrombosis at 12 months
  • Bleeding [ Time Frame: 48 hour and 12 months ]
    Bleeding at 48 hr and 12 months
  • Treatment costs [ Time Frame: 12 months ]
    Treatment costs 12 months
Current Other Pre-specified Outcome Measures
 (submitted: July 21, 2020)
  • A Comparison of the Number of Patients in Both Groups With Treated Lesions With FFR ≤ 0.80 Versus Patients With Untreated Lesions With FFR ≤ 0.80; [ Time Frame: 3 year ]
    FFR+/PCI+ vs FFR+/PCI- Comparison of patients having FFR positive lesions that underwent revascularization during index procedure or in staged procedures within 45 days (groups A+C, n=202 patients) with patients having FFR positive lesions that did not undergo revascularization (group D, n=231 patients),
  • Comparison of Acute Versus Staged PCI for Lesions With FFR ≤ 0.80 [ Time Frame: 3 year ]
    Comparison of acute versus staged PCI treatment for lesions with FFR
  • Comparison of PCI vs Medical Therapy in FFR Negative Lesions [ Time Frame: 3 year ]
    comparison of patients receiving staged PCI treatment of FFR-negative lesions in the non-IRA (decision made by referring physician who was blinded to FFR results) and patients receiving medical therapy for FFR-negative lesions in the non-IRA
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison Between FFR Guided Revascularization Versus Conventional Strategy in Acute STEMI Patients With MVD.
Official Title  ICMJE Fractional Flow Reserve Guided Primary Multivessel Percutaneous Coronary Intervention to Improve Guideline Indexed Actual Standard of Care for Treatment of ST-elevation Myocardial Infarction in Patients With Multivessel Coronary Disease
Brief Summary

The Compare-Acute trial is a prospective randomised trial in patients with multivessel disease, who are admitted into hospital with a ST-elevation Myocardial Infarction. The purpose of the study is to compare a FFR guided multivessel PCI taking place during the primary PCI with a primary PCI of the culprit vessel only.

Patients will be enrolled after successful revascularisation of the culprit vessel. Patients that have at least one lesion with a diameter of stenosis of more than 50% on visual estimation, feasible (operators judgement) for treatment with PCI in a non-infarct related artery, will be randomised either to the FFR guided complete revascularisation arm or staged revascularisation by proven ischemia or persistence of symptoms of angina.

Approximately 885 patients will be entered in the study.

Study hypothesis: FFR-guided complete percutaneous revascularisation of all flow-limiting stenoses in the non-IRA performed within the same procedure as the primary PCI or within the same hospitalisation will improve clinical outcomes compared to the staged revascularisation, guided by prove of ischemia or clinical judgment, as recommended from the guidelines.

Detailed Description

Background of the study: At the moment the general opinion is divided over the way the non culprit lesions in patients presenting with STEMI should be treated. While the previous guidelines stead that these lesions should be treated in a second time ( ie not during the primary intervention) the actual guidelines do not touch this argument. The reason is that the studies where the previous guidelines were based are old. Meanwhile small sized randomised trials from EU region have proven favourable outcomes with NON infarct related artery during the primary procedure while registers (non randomised trials) from USA still recommend the staged treatment. For this reason we have decided to perform a randomised study to address this issue incorporating the state of the art diagnosis and treatment, as well as the new medical therapy and PCI techniques.

Objective of the study: FFR-guided complete percutaneous revascularisation of all flow-limiting stenoses in the non-IRA performed within the same procedure as the primary PCI or within the same hospitalisation will improve clinical outcomes compared to the staged revascularisation, guided by prove of ischemia or clinical judgment, as recommended from the guidelines

Study design: Prospective, 1: 2 randomisation. FFR guided revascularisation during primary PCI (1) versus following actual guidelines (2)

Study population: All STEMI patients between 18-85 years who will be treated with primary PCI in < 12 h (more than 12 hr if persisting pain allowed) after the onset of symptoms and have at least one stenosis of >50% in a non-IRA judged feasible for treatment with PCI.

Intervention (if applicable): FFR-guided complete percutaneous revascularisation of all flow-limiting stenoses in the non-IRA performed within the same procedure as the primary PCI or within the same hospitalisation will improve clinical outcomes compared to the staged revascularisation, guided by prove of ischemia or clinical judgment, as recommended from the guidelines

Primary study parameters/outcome of the study: Composite endpoint of all cause mortality non-fatal Myocardial Infarction, any Revascularisation and Stroke (MACCE) at 12 months

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Myocardial Infarction
  • Multivessel Coronary Artery Disease
Intervention  ICMJE
  • Procedure: FFR-guided revascularisation strategy
    FFR-guided revascularisation strategy
  • Procedure: randomised to guidelines group
    Staged revascularisation by proven ischemia or persistence of symptoms of angina
Study Arms  ICMJE
  • Active Comparator: FFR-guided revascularisation strategy
    In the FFR-group all flow limiting (FFR≤0.80) lesions will receive treatment by PCI and stenting. The non-IRA PCI should be performed during the same intervention. Exceptions can be made for complex lesions where the operator estimates that the revascularisation procedure will require significant contrast overload which may lead to deterioration of cardiac and renal function of the patient. Such procedures can be performed in a second procedure which should take place within the same hospitalisation. All lesions with a FFR measurement of >0.80 will not be treated.
    Intervention: Procedure: FFR-guided revascularisation strategy
  • Placebo Comparator: randomised to guidelines group
    In the randomised to guidelines group the procedure will stop after the FFR measurements and the patient will be referred to his treating cardiologist who will decide whether a staged PCI of the non-IRA artery should take place. The treating cardiologist will be blinded for the FFR measurements (but not angiographic imaging) and must make a decision based on conventional non-invasive ischemia detecting tests or clinical signs and symptoms i.e. very typical angina symptoms in patients with angiographic significant stenosis).
    Intervention: Procedure: randomised to guidelines group
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 21, 2011)
885
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 31, 2018
Actual Primary Completion Date October 31, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • All patients between 18-85 years presenting with STEMI who will be treated with primary PCI in < 12 h after the onset of symptoms* and have at least one stenosis of >50% in a non-IRA on QCA or visual estimation of baseline angiography and judged feasible for treatment with PCI by the operator.

    • Patients with symptoms for more than 12 hr but ongoing angina complaints can be randomised

Exclusion Criteria:

  1. Left main stem disease (stenosis > 50%)
  2. STEMI due to in-stent thrombosis
  3. Chronic total occlusion of a non-IRA
  4. Severe stenosis with TIMI flow ≤ II of the non-IRA artery.
  5. Non-IRA stenosis not amenable for PCI treatment (operators decision)
  6. Complicated IRA treatment, with one or more of the following;

    • Extravasation,
    • Permanent no re-flow after IRA treatment (TIMI flow 0-1),
    • Inability to implant a stent
  7. Known severe cardiac valve dysfunction that will require surgery in the follow-up period.
  8. Killip class III or IV already at presentation or at the completion of culprit lesion treatment.
  9. Life expectancy of < 2 years.
  10. Intolerance to Aspirin, Clopidogrel, Prasugrel, Ticagrelor, Heparin, Bivaluridin, or Everolimus and known true anaphylaxis to prior contrast media of bleeding diathesis or known coagulopathy.
  11. Gastrointestinal or genitourinary bleeding within the prior 3 months,
  12. Planned elective surgical procedure necessitating interruption of thienopyridines during the first 6 months post enrolment.
  13. Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
  14. Pregnancy or planning to become pregnant any time after enrolment into this study.
  15. Inability to obtain informed consent.
  16. Expected lost to follow-up.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Czechia,   Germany,   Hungary,   Netherlands,   Norway,   Poland,   Singapore,   Sweden
Removed Location Countries Czech Republic,   Luxembourg
 
Administrative Information
NCT Number  ICMJE NCT01399736
Other Study ID Numbers  ICMJE Compare-Acute
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Maasstad Hospital
Study Sponsor  ICMJE Maasstad Hospital
Collaborators  ICMJE Abbott Medical Devices
Investigators  ICMJE
Principal Investigator: Peter Smits, MD. PHD Maastadhospital / MCR
Study Chair: Elmir Omerovic, MD PhD Sahlgrenska Hospital Götheborg
Study Chair: Gert Richardt, MD PhD Herzzentrum Segeberger Kliniken
Study Chair: Franz-Josef Neumann, MD PhD Herz-Zentrum Bad Krozingen
PRS Account Maasstad Hospital
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP